Criminal Law Keyed to Kadish
United States v. Guidant LLC
two of the models of implantable defibrillators which Guidant LLC (D) manufactured for people suffering from fast heart rhythms, had defects which could result in sudden cardiac arrest. Guidant (D) however failed to notify the Food and Drug Administration (FDA) after it had discovered these defects. This made Guidant (D) to plead guilty to two misdemeanor counts of making material false statement on reports to the FDA and not notifying the FDA immediately about the defects. A criminal plea agreement of $253,962,251 and a separate criminal forfeiture of $42,079,685 were agreed upon by the Government (P) and Guidant (D). Not included however in the agreement was a term of probation. The agreement was considered by the federal trial court which eventually issued this decision.
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